Autologous PRP and Focal Shock Waves for Erectile Dysfunction
NCT ID: NCT06433596
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
116 participants
INTERVENTIONAL
2024-05-06
2026-12-31
Brief Summary
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The main questions it aims to answer are:
* Does Combined therapy PRP + SWT improve erection in men with moderate or mild to moderate erectile dysfunction?
* What medical problems do participants have when receiving Combined therapy PRP + SWT?
Researchers will compare Combined therapy PRP + SWT to placebo therapy (a look-alike substance that contains no PRP) to see if Combined therapy PRP + SWT works to treat moderate or mild to moderate erectile dysfunction.
Participants will:
* Take a lab test to evaluate their platelets
* Answer some questionnaires to assess your erectile function
* Receive Combined therapy PRP + SWT (3 sessions PRP + 6 sessions SWT) or placebo therapy for 9 weeks
* Visit the clinic one month, 3 months, and 6 months after finishing the treatment for checkups and tests
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Detailed Description
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Study design: Randomized, double-blind, placebo-controlled clinical trial, phase III. The study will include four groups:
* G1 - Autologous PRP: Autologous Platelet Rich Plasma (PRP) + placebo shock waves
* G2 - combined therapy: Autologous PRP + focal shock waves
* G3 - placebo control: Placebo PRP + placebo shock waves
* G4 - shock waves: PRP placebo + shock waves
116 subjects will be included, who will be randomized in a 1:1:1:1 ratio in the four groups described above.
The change in the International Index of Erectile Function - Erectile Function domain (IIEF-EF) score, the change in the Erection Hardness Score (EHS), and the adverse events will be evaluated at the end of treatment, and 1, 3, and 6 months of follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Autologous PRP
3 injections of 10 cc of autologous Platelet Rich Plasma (PRP) + 6 sessions of placebo shock waves
Platelet-rich plasma
3 injections of 10 cc of autologous Platelet Rich Plasma (PRP), weeks 1, 5 and 9
Sham shock waves therapy
6 sessions of sham shock waves, 1 per week
Combined therapy
3 injections of 10 cc of autologous PRP + 6 sessions of focal shock waves.
Platelet-rich plasma
3 injections of 10 cc of autologous Platelet Rich Plasma (PRP), weeks 1, 5 and 9
Shock waves therapy
6 sessions of focal shock waves, 1 per week
Placebo control
3 injections of 10 cc of saline solution + 6 sessions of placebo shock waves
Placebo PRP
3 injections of 10 cc of saline solution, weeks 1, 5 and 9
Sham shock waves therapy
6 sessions of sham shock waves, 1 per week
Shock waves
3 injections of 10 cc of saline solution + 6 sessions of waves of focal shock.
Shock waves therapy
6 sessions of focal shock waves, 1 per week
Placebo PRP
3 injections of 10 cc of saline solution, weeks 1, 5 and 9
Interventions
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Platelet-rich plasma
3 injections of 10 cc of autologous Platelet Rich Plasma (PRP), weeks 1, 5 and 9
Shock waves therapy
6 sessions of focal shock waves, 1 per week
Placebo PRP
3 injections of 10 cc of saline solution, weeks 1, 5 and 9
Sham shock waves therapy
6 sessions of sham shock waves, 1 per week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Erectile dysfunction present for more than 3 months in more than 50% of intercourse.
3. Baseline score of the IIEF-EF questionnaire between 11 and 21.
4. Stable heterosexual relationship of at least 6 months.
5. Commitment to have at least 3 vaginal sexual relations per month after completing treatment.
6. Commitment not to use other natural, oral, or intracavernous pharmacological treatments during the treatment and up to 6 months after its completion.
7. A patient who agrees to voluntarily enter the study by signing an informed consent.
Exclusion Criteria
2. Patients with an international normalized ratio (INR) greater than 3.
3. Patients with sickle cell anemia.
4. Patients with clinical suspicion of hypogonadism (ADAM positive).
5. Acromegaly, gigantism, Addison disease, hyperprolactinemia, androgen deficiency.
6. Active bladder, prostate, or colon cancer.
7. Radical prostatectomy or other radical pelvic surgery.
8. History of pelvic radiotherapy.
9. Spinal cord injury or other neurological disease associated with erectile dysfunction.
10. Penile anatomical dysfunction, penile implant.
11. Platelet diseases or coagulation disorders.
12. Treatment with oral anticoagulants.
13. Platelet count outside the normal range (150 to 400 × 109/L).
14. Patients with active infections or lesions of the penis or pubic area.
15. Patients with erectile dysfunction secondary to drug treatment (antiandrogen therapy, Alpha-blockers for benign prostatic hyperplasia, use of corticosteroids, antiparkinsonian drugs, antipsychotics).
16. Patients with erectile dysfunction of psychological origin.
17. Abuse of psychoactive substances (including alcohol).
18. Cognitive or physical illness that prevents you from participating in the study, self-filling out the questionnaires, or attending therapies and controls.
19. Inability to attend therapies and controls.
18 Years
MALE
Yes
Sponsors
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Boston Medical Group
INDUSTRY
Elexial Research Limited
OTHER
Responsible Party
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Principal Investigators
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Jose Benitez, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Group
Locations
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Boston Medical Group Spain S.L.U
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-002985-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PRP-SW-03
Identifier Type: -
Identifier Source: org_study_id
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